- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02574689
Home-based, Individually-tailored Physical Activity Print Intervention for African American Women in the Deep South (HIPP)
연구 개요
상세 설명
80 women will receive the HIPP Intervention or Wellness Contact Control. While main outcomes are focused on feasibility and acceptability, physical activity, fitness, and body weight and composition data will be collected at baseline, 6 months, and 12 months, along with blood draws.
HIPP Intervention: The physical activity intervention is based on the Social Cognitive Theory and Transtheoretical Model and, emphasizes behavioral strategies for increasing activity levels (i.e., goal-setting, self-monitoring, problem-solving barriers, increasing social support, rewarding oneself for meeting physical activity goals), and includes regular mailings (three mailings in month 1, two mailings in months 2 and 3, one mailing in months 4, 5, 6, 8, and 10) of physical activity manuals that are matched to the participant's current level of motivational readiness and individually-tailored computer expert system feedback reports. Computer expert system feedback reports will be based on participants' monthly update survey data and include information on:
- current stage of motivational readiness for physical activity;
- increasing self- efficacy (i.e., confidence) for physical activity participation;
- weighing the pros and cons of engaging in physical activity (decisional balance);
- social support from family and friends for physical activity participation;
- outcome expectations (beliefs regarding the consequences of physical activity participation);
- perceived enjoyment of physical activity;
- how the participant compares to her prior responses (progress feedback);
- how the participant compares to individuals who are physically active and with national guidelines (normative feedback);
- self monitoring of physical activity behavior (using pedometers and activity logs to track the total steps and minutes of moderate intensity physical activity per day).
The computer expert system draws from a bank of 330 messages addressing different levels of psychosocial and environmental factors affecting physical activity. Intervention participants will also receive tip sheets addressing physical activity barriers specific to African American women in the Deep South (as identified during our focus groups and comprehensive literature review).
Wellness Contact Control Condition: Cancer prevention information on topics other than physical activity (e.g., "Add Fruits and Veggies to Your Diet") from the American Cancer Society (ACS) website (www.cancer.org) will be mailed to control participants at the same time points that the HIPP Intervention participants receive their physical activity intervention materials.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35233
- University of Alabama at Birmingham
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- African American
- Post-menopausal (defined as not having menstrual periods for at least 12 months)
- Not taking hormone replacement therapy
- Healthy (BMI 18.5-40; No history of heart disease, myocardial infarction, angina, stroke, or orthopedic conditions which limit mobility, or any serious medical condition that would make physical activity unsafe; no psychiatric hospitalization in past 3 years).
- Not taking medication that may impair physical activity tolerance or performance (e.g., beta blockers).
- Not planning to move from the area for the next 12 months
- Willing to be randomized to either study arm and adhere to study protocol
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: HIPP Intervention
The physical activity intervention emphasizes behavioral strategies for increasing activity levels (i.e., goal-setting, self-monitoring, problem-solving barriers, increasing social support, rewarding oneself for meeting physical activity goals), and includes regular mailings (three mailings in month 1, two mailings in months 2 and 3, one mailing in months 4, 5, 6, 8, and 10) of physical activity manuals that are matched to the participant's current level of motivational readiness and individually-tailored computer expert system feedback reports.
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The physical activity intervention is based on the Social Cognitive Theory and Transtheoretical Model and includes motivation-matched physical activity manuals and individually-tailored computer expert system feedback reports.
Tailored reports are based on participants' monthly update survey data and cover: 1) current stage of change; 2) self-efficacy; 3) decisional balance; 4) social support; 5) outcome expectations; 6) enjoyment; 7) progress feedback; 8) normative feedback; 9) self regulation.
The computer expert system draws from a bank of 330 messages addressing different levels of psychosocial and environmental factors affecting physical activity.
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|
활성 비교기: Wellness Contact Control
Cancer prevention information on topics other than physical activity (e.g., "Add Fruits and Veggies to Your Diet") from the ACS website (www.cancer.org)
will be mailed to control participants at the same time points that the HIPP Intervention participants receive their physical activity intervention materials.
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Cancer prevention information on topics other than physical activity (e.g., "Add Fruits and Veggies to Your Diet") from the American Cancer Society website (www.cancer.org)
are mailed to control participants at the same time points that the HIPP Intervention participants receive their physical activity intervention materials.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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7-Day Physical activity Recall interview (change from baseline in 7-Day physical activity recall interview)
기간: baseline and 6 months
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minutes/week of moderate intensity or greater physical activity
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baseline and 6 months
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7-Day Physical activity Recall interview (change from baseline in 7-Day physical activity recall interview)
기간: baseline and 12 months
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minutes/week of moderate intensity or greater physical activity
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baseline and 12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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6 minute walk test
기간: baseline, 6 months, 12 months
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meters walked in 6 minutes
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baseline, 6 months, 12 months
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body mass index
기간: baseline, 6 months, 12 months
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kg/m^2
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baseline, 6 months, 12 months
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waist circumference
기간: baseline, 6 months, 12 months
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cm
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baseline, 6 months, 12 months
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body impedance analyses
기간: baseline, 6 months, 12 months
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% body fat
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baseline, 6 months, 12 months
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Social Support for exercise scale
기간: baseline, 6 months, 12 months
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range=0-65 for both friends and family subscales, with higher scores indicating more social support
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baseline, 6 months, 12 months
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Outcome expectations scale
기간: baseline, 6 months, 12 months
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range= 1-5, with higher scores representing more outcome expectations
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baseline, 6 months, 12 months
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Physical Activity Enjoyment scale
기간: baseline, 6 months, 12 months
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range=18-126, with higher scores indicating more enjoyment
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baseline, 6 months, 12 months
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accelerometers
기간: baseline, 6 months, 12 months
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minutes/week of moderate intensity or greater physical activity
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baseline, 6 months, 12 months
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Stages of Readiness Measure
기간: baseline, 6 months, 12 months
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categorize participants into stages of change (pre contemplation, contemplation, preparation, action, maintenance)
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baseline, 6 months, 12 months
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Self -Efficacy for physical activity scale
기간: baseline, 6 months, 12 months
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range= 1-5, with higher scores representing more self-efficacy
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baseline, 6 months, 12 months
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processes of change measure
기간: baseline, 6 months, 12 months
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range= 1-5, with higher scores representing greater use of cognitive and/or behavioral processes of change
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baseline, 6 months, 12 months
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Decisional Balance scale
기간: baseline, 6 months, 12 months
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scores >0 indicate more advantages than disadvantages to physical activity
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baseline, 6 months, 12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Dori Pekmezi, PhD, University of Alabama at Birmingham
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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